Use of Sensory Substitution to Improve Arm Control After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMarquette University
About this trial
Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
stroke survivors who can perform our stabilization and grip modulation tasks and who
had a single ischemic or hemorrhagic stroke of the middle cerebral artery (MCA) in the chronic state of recovery (> 6 months post-stroke).
ability to give informed consent and be able to follow two-stage instructions.
mild-to-moderate motor impairment as assessed using the upper extremity (UE) portion of the Fugl-Meyer Motor Assessment (FM); i.e., UE-FM score between 28 and 50 (inclusive) out of a possible 66.
Disqualifiers
Inability of subjects to give informed consent or follow two-stage instructions.
subjects with a bleeding disorder.
subjects with fixed contractures or a history of tendon transfer in the involved limb.
subjects with a diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any disease that might interfere with neuromuscular function.
Trial design
Design model
Parallel
Treatments tested in this trial
Vibrotactile stimulation
BehavioralNon-invasive, computer-controlled miniature tendon vibrators, similar to those used in off-the-shelf activity monitors.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Stroke Cohort - Progressive TrainingExperimental treatment 1 intervention
Group B: Stroke Cohort - Whole Task TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Root Mean Square Kinematic Error
orthogonal distance between target and hand position during reaching and stabilizing
Time frame
across experimental sessions spanning a typical time frame of 4 to 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marquette University
Lead sponsor
Medical College of Wisconsin
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov